AO-176 in Multiple Solid Tumor Malignancies
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ClinicalTrials.gov Identifier: NCT03834948 |
Recruitment Status :
Active, not recruiting
First Posted : February 8, 2019
Last Update Posted : August 5, 2022
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Tracking Information | |||||||
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First Submitted Date ICMJE | February 4, 2019 | ||||||
First Posted Date ICMJE | February 8, 2019 | ||||||
Last Update Posted Date | August 5, 2022 | ||||||
Actual Study Start Date ICMJE | February 4, 2019 | ||||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Safety Of AO-176 assessed by adverse events and laboratory abnormalities [ Time Frame: Up to 12 months ] Evaluate the safety of AO-176 measured by the number adverse events, serious adverse events and lab abnormalities.
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
AO-176 Anti-Tumor Activity assessed by changes in response criteria [ Time Frame: Up to 12 months ] Evaluate Objective response rate of AO-176 using RECIST and iRECIST.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | AO-176 in Multiple Solid Tumor Malignancies | ||||||
Official Title ICMJE | A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AO-176 | ||||||
Brief Summary | This is a first-in-human, Phase 1/2 multi-center, open-label, dose escalation and expansion study of AO-176 which will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and clinical effects of AO-176 in patients with advanced solid tumors. | ||||||
Detailed Description | This is a first-in-human, Phase 1/2 multicenter, open-label, dose escalation and expansion study of AO-176 in patients with solid tumors. Part A of this study will examine escalating repeat doses of AO-176 monotherapy in patients with select advanced solid tumors, including epithelial ovarian carcinoma (EOC), which will include primary peritoneal and fallopian tube carcinoma; squamous cell carcinoma of the head and neck; endometrial carcinoma; castration resistant prostate cancer; non-small cell lung adenocarcinoma; papillary thyroid carcinoma; pleural or peritoneal malignant mesothelioma; and gastroesophageal adenocarcinoma, for which standard therapy proven to provide clinical benefit does not exist or is no longer effective. Part B and Part C of this study will examine escalating repeat doses of AO-176 in combination with paclitaxel (Part B) or pembrolizumab (Part C) in platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; endometrial carcinoma; and gastric adenocarcinoma/gastroesophageal adenocarcinoma. The monotherapy and combination dose escalation portions of the study utilize a classic 3+3 design, with enrollment of 3 patients per cohort and expansion of the cohort in the event of a dose-limiting toxicity (DLT). Once the maximum-tolerated dose (MTD)/recommended phase 2 dose (RP2D) has been established in dose escalation, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176 as monotherapy, in combination with paclitaxel, and in combination with pembrolizumab. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model Description: Each dose escalation cohort will initially recruit 3 patients to receive AO-176 or AO-176 + paclitaxel or AO-176 + pembrolizumab in a standard 3+3 design; the cohort will be expanded in the event of a DLT. Once the MTD/RP2D has been established for monotherapy, AO-176 + paclitaxel or AO-176 + pembrolizumab, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy. Primary Purpose: Treatment |
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Condition ICMJE | Solid Tumor | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Andrejeva G, Capoccia BJ, Hiebsch RR, Donio MJ, Darwech IM, Puro RJ, Pereira DS. Novel SIRPalpha Antibodies That Induce Single-Agent Phagocytosis of Tumor Cells while Preserving T Cells. J Immunol. 2021 Feb 15;206(4):712-721. doi: 10.4049/jimmunol.2001019. Epub 2021 Jan 11. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
183 | ||||||
Original Estimated Enrollment ICMJE |
90 | ||||||
Estimated Study Completion Date ICMJE | March 2023 | ||||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT03834948 | ||||||
Other Study ID Numbers ICMJE | AO-176-101 KEYNOTE-C49 ( Other Identifier: Merck Sharp & Dohme Corp. ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Arch Oncology | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Arch Oncology | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Merck Sharp & Dohme LLC | ||||||
Investigators ICMJE |
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PRS Account | Arch Oncology | ||||||
Verification Date | August 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |